Trials / Completed
CompletedNCT02703714
Pembrolizumab and GM-CSF in Biliary Cancer
Phase II Trial of Pembrolizumab (MK-3475) With GM-CSF Induction in Advanced Biliary Cancers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Robin Kate Kelley · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label phase II trial to examine efficacy and safety of a novel combination of pembrolizumab plus induction GM-CSF in patients with advanced biliary cancers treated at University of California, San Francisco (UCSF). This phase II study will examine the efficacy and safety of the novel combination of pembrolizumab plus induction GM-CSF in advanced biliary cancer patients with the hypotheses that the combination may increase proportion of patients with overall response compared to contemporary historical controls, with acceptable safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | 200 mg given intravenously (IV) |
| DRUG | Sargramostim | 250 µg given subcutaneously (SC) |
Timeline
- Start date
- 2016-05-06
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2016-03-09
- Last updated
- 2022-01-25
- Results posted
- 2022-01-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02703714. Inclusion in this directory is not an endorsement.